← Back to catalogue

Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
In-line CPAP set, non-nebulizing FDA UDI
Device Name
*CUSTOM* Montgomery CPAP/Capnography Kit (5-Set) FDA UDI
Model / Reference
8600-01516 FDA UDI
Description
*CUSTOM* Montgomery CPAP/Capnography Kit (5-Set) FDA UDI

Identifiers

Catalog Number
8600-01516 FDA UDI
Primary DI / UDI-DI
00810094577162 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
In-line CPAP set, non-nebulizing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: In-line CPAP set, non-nebulizing

Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as In-line CPAP set, non-nebulizing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI a8b965d6-c5dc-428e-b276-a076696e8f96 34 fields · synced Jun 8, 2026